Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion

September 21, 2015 updated by: Dr. Robert Campbell, Queen's University
This study will evaluate the effect of the timing of treatment completion in two-staged selective laser trabeculoplasty therapy on intraocular pressure lowering effect.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

SLT therapy is used as an IOP lowering agent in patients with glaucoma. It is unknown whether the timing of a 2-staged approach to the laser therapy will result in better IOP lowering effect.

This study will evaluate the timing (early vs. late completion of SLT therapy) and determined the IOP lowering effect following the interventions.

Arm 1: Early Completion SLT

180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees on Day 2

Arm 2: Late Completion SLT

180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees at the 1 month follow up visit.

Primary Outcome: IOP (mmHg).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Hotel Dieu Hospital & Queen's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age
  • primary open angle glaucoma or pseudoexfoliation glaucoma

Exclusion Criteria:

  • Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SLT Early Completion (Arm 1)
Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degree on Day 2
Procedure: selective laser trabeculoplasty - early completion
180 degrees of laser on day 1 and other 180 degrees on day 2.
Active Comparator: SLT Late Completion (Arm 2)
Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degrees at 1 month follow up appointment.
Procedure: Selective laser trabeculoplasty - late completion
180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intraocular pressure lowering
Time Frame: 1 month following procedure
1 month following procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
intraocular pressure lowering
Time Frame: 3, 6, 12 and 24 months following procedure
3, 6, 12 and 24 months following procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Robert J Campbell, MD, Queen's University, Kingston, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 29, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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